Fosamax and Osteoporosis

With approval by the Federal Drug Administration in 1995, Fosamax became the first bisphosphonate prescribed for the prevention and treatment of osteoporosis. Prior to Fosamax, the leading form of osteoporosis treatment was hormone replacement therapy (HRT). Many orthopedic experts, however, voice warning over Merck's encouragement of the use of Fosamax for long periods of time. Many are worried that long-term use of continuous Fosamax treatment will interfere with the normal process of bone turnover, and in doing so will only end up causing the conditions Fosamax is meant to prevent- fractures and weakened bones.

Bones are constantly being remodeled- breaking down old bone and growing newer, healthier bone. Fosamax, however, slows this turnover. The drug prevents replacement of new bone tissue by stopping the resportion of old bone tissue. If old bone tissue is not replaced, the bone becomes brittle and prone to fracture. In a 2004 article in the Annals of Internal Medicine, Dr. Susan Ott of the University of Washington offered words of caution. "The drugs deposit in the skeleton for many years, depressing the bone resorption rate as well as the bone formation rate.

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Long-term studies also raise concerns about Fosamax's possible interference with bone remodeling. The Fracture Intervention Trial, performed on 1099 women at eleven clinics across the country. Its researchers concluded that continued use of Fosamax becomes counterproductive after five years of use. The women in the study were given Fosamax for five years. Then half of the women were randomly given Fosamax for another five years, while the rest of the women in the study received a placebo for the same length of time. The study showed that despite the decreased bone density displayed by the women who received the placebo, the women who continued taking Fosamax had essentially the same number of fractures as the women who had taken the placebo.

The Fracture Intervention Trial expressed an important point: increased bone density does not necessarily correlate with good bone quality. Because Fosamax increases bone mineralization by precluding turnover of old bone tissue, the bone will become denser. Unfortunately, though, when bone remodeling stops, dense or not, the bones lose strength. Bone turnover is a natural part of maintaining bone health. By decreasing bone resorption (and therefore bone formation), damage (even on a microscopic scale) that occurs regularly to the bone but is not replaced by new bone tissue might continue to worsen after long-term use of Fosamax. "Why do we remodel in the first place?'' asked Dr. Mitchell Schaffler, director of orthopedic research at the Mount Sinai School of Medicine, in a 2004 New York Times article. ''It keeps the quality of bone up over time. If you shut it down to try to prevent bone loss, the question is, will you still be able to maintain your tissue?''

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Recent lawsuits filed against Merck accuse the drug maker of irresponsibly marketing Fosamax to individuals who do not need the drug. Physicians have expressed similar allegations out of concern for their patients. Such claims assert that Merck began an intense marketing campaign for Fosamax under which it began directing its advertisements at 40 and 50 year old women just on the brink of menopause, as opposed to targeting women above the age of 60 - the group most at risk for osteoporosis. Orthopedic experts, as well as the plaintiffs in recent lawsuits, claim that most of the women who are prescribed Fosamax do not need it. Dr. Ott has noted, "if you're a healthy 50 year-old - an average woman going through menopause - your chances of getting a fracture are very low, yet they are pushing the drug right at that age group." Doctors fear that a regimen of Fosamax in a woman with currently healthy, dense bone could cause premature bone weakness and lead to the very fractures that Fosamax aims to prevent.

If you or a member of your family has taken Fosamax and experienced harmful side effects, such as osteonecrosis of the jaw, please seek immediate medical attention. If you would like to discuss your rights surrounding an injury caused by Fosamax, please fill out this short form and a member of Seeger Weiss's experienced legal staff will contact you. Initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has offices located in both New York City and New Jersey.